MAUDE Adverse Event Report: THEKEN COMPANIES INSITU BLADE FEMORAL STEM; TOTAL HIP ARTHROPLASTY

Model Number	10-13-0013
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intra-operative fractures may be multifactorial and can depend on patient bone quality and surgeon technique.
Event or Problem Description
Intra-operative periprosthetic fracture during femoral stem insertion.Surgeon used cerclage cables to reduce fracture and reinserted the femoral stem.

• Brand Name: INSITU BLADE FEMORAL STEM
• Common Device Name: TOTAL HIP ARTHROPLASTY
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 11246125
• Report Number: 3002498892-2021-00001
• Device Sequence Number: 3754417
• Product Code: LPH
• UDI-Device Identifier: 00816127028410
• UDI-Public: 816127028410
• Combination Product (Y/N): N
• PMA/510(K) Number: K192071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 10-13-0013
• Device Lot Number: 1790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention